{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:25:53Z","timestamp":1792070753271,"version":"4.4.0"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T00:00:00Z","timestamp":1687219200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"NCCN Oncology Research Program"},{"name":"Taiho Oncology, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,10,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We sought to determine the safety and efficacy of trifluridine\/tipiracil in combination with irinotecan in a phase II trial setting for refractory, advanced unresectable biliary tract carcinoma (BTC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 28 patients (27 were evaluable) with advanced BTCs who progressed on at least one prior systemic therapy were enrolled and were treated with trifluridine\/tipiracil 25 mg\/m2 (days 1-5 of 14-day cycle) and irinotecan 180 mg\/m2 (day 1 of the 14-day cycle). The primary endpoint for the study was 16-week progression-free survival (PFS16) rate. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were pre-specified secondary endpoints.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 27 patients, PFS16 rate was 37% (10\/27; 95% CI: 19%-58%), thereby meeting the criteria for success for the primary endpoint. The median PFS and OS of the entire cohort were 3.9 months (95% CI: 2.5-7.4) and 9.1 months (95% CI: 8.0-14.3), respectively. In the patients evaluable for tumor response (n = 20), the ORR and DCR were 10% and 50%, respectively. Twenty patients (74.1%) had at least one grade 3 or worse adverse event (AE), and 4 patients (14.8%) had grade 4 AEs. A total of 37% (n = 10\/27) and 51.9% (n = 14\/27) experienced dose reductions in trifluridine\/tipiracil and irinotecan, respectively. Delay in therapy was noted in 56% of the patients while 1 patient discontinued the therapy, primarily due to hematologic AEs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The combination of trifluridine\/tipiracil plus irinotecan is a potential treatment option for patients with advanced, refractory BTCs with good functional status and no targetable mutations. A larger randomized trial is needed to confirm these results. (ClinicalTrials.gov Identifier: NCT04072445)<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad144","type":"journal-article","created":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T19:07:16Z","timestamp":1687288036000},"page":"917-e966","source":"Crossref","is-referenced-by-count":5,"title":["Phase II Trial of Trifluridine\/Tipiracil Plus Irinotecan in Patients with Advanced, Refractory Biliary Tract Carcinoma"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8878-1283","authenticated-orcid":false,"given":"Sri Harsha","family":"Tella","sequence":"first","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Foster","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4640-8832","authenticated-orcid":false,"given":"Shi","family":"Qian","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tran","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitesh J","family":"Borad","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Scottsdale, AZ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert R","family":"McWilliams","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven R","family":"Alberts","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Wee Ma","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sakti","family":"Chakrabarti","sequence":"additional","affiliation":[{"name":"Department of Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University , Cleveland, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Briant","family":"Fruth","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaclynn","family":"Wessling","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Mayo Clinic , Rochester, MN , 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